Registration Dossier

Administrative data

Description of key information

No data are available for the target substance Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt. Therefore, read-across from structural analogue substances has been applied.

skin irritation (OECD 404): irritating

Read-across from structural analogue source substances Sodium octyl sulfate (CAS 142-31-4), Sulfuric acid, mono (2-ethylhexyl) ester, sodium salt (CAS 126-92-1) and Sodium dodecyl sulfate (CAS 151-21-3)


eye irritation (OECD 405): highly irritating/corrosive

Read-across from structural analogue source substances Sodium dodecyl sulfate (CAS 151-21-3), Sulfuric acid, mono-C10-16-alkyl esters, sodium salts (CAS 68585-47-7) and Sulfuric acid, mono-C12-13-alkyl esters, potassium salts (CAS 91783-22-1)

SCLs for eye irritation / severe eye damage according to Regulation (EC) No. 1272/2008 (CLP):
>= 10% < 20% Eye Irrit. Cat. 2, H319
< 10% no classification for eye irritation / severe eye damage

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD guideline 404. However some deviations occurred (e.g. 24 h occluded exposure, limited data on test substance).
Qualifier:
equivalent or similar to
Guideline:
other: Draize test
Deviations:
yes
Remarks:
e.g. 24 h occluded exposure, limited data on test substance
Qualifier:
according to
Guideline:
other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no
Remarks:
Study was conducted prior to implementation of GLP.
Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: Individually in metal cages
- Diet (ad libitum): Standard rabbit food - NAFAG Gossau SG
- Water (ad libitum)
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
3 males and 3 females
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.61
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 h

Table 1: Details on results

Observation time

Rabbit No.

1

2

3

4

5

6

er

ed

er

ed

er

ed

er

ed

er

ed

er

ed

24 h

1

0

1

0

1

1

1

1

2

1

1

1

48 h

1

0

1

0

0

0

0

0

1

0

1

0

72 h

0

0

0

0

0

0

0

0

0

0

0

0

Mean value

24 + 48 + 72 h

0.67

0

0.67

0

0.33

0.33

0.33

0.33

1.0

0.33

0.67

0.33

Mean value

24 + 48 + 72 h,

all animals

0.61

0.22

 

 

 

 

 

 

 

 

 

 

er: erythema, ed: edema

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August 22- October 13, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Approx. 4 - 8 months
- Weight at study initiation: 4.41 kg –5.01 kg
- Housing: Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2. Fully air-conditioned rooms.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 30 – 70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
The solid test item was minimally moistened with a suitable amount of highly deionized water to guarantee skin contact immediately before test-item application
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of undiluted test item

VEHICLE
Minimally moistened with highly deionized water
Duration of treatment / exposure:
4h
Observation period:
Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test item was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4h

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animal with equal erythema score of 3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
The following test item-related clinical observations were recorded during the course of the study:

• Well-defined to moderate erythema (grade 2 to 3)
• Very slight to severe edema (grade 1 to 4)
• Scaling
• Severe scaling
• Incrustations
• Eczema like skin lesions
• Erythema and edema beyond the application site
• Bloody, yellowish discolored incrustations
• Yellowish discoloration of the application site
• Plaque-like incrustations
Interpretation of results:
other: Skin irrit. 2, H315. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Conclusions:
Test item shows a skin irritating potential under the test conditions chosen.
Executive summary:

The potential of the test item to cause acute dermal irritation or corrosion was assessed according to OECD TG 404 by a single topical application of an amount of 0.5 g for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing one additional animal per step up to a maximum number of three animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off.

The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until day 14.

 

The following test item-related clinical observations were recorded during the course of the study:

  • Well-defined to moderate erythema (grade 2 to 3)
  • Very slight to severe edema (grade 1 to 4)
  • Scaling
  • Severe scaling
  • Incrustations
  • Eczema like skin lesions
  • Erythema and edema beyond the application site
  • Bloody, yellowish discolored incrustations
  • Yellowish discoloration of the application site
  • Plaque-like incrustations

The cutaneous reactions were not reversible in all animals during the course of the study.

Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.0 and 3.0 for erythema and 2.0, 3.3 and 3.0 for edema.

 

Considering the described cutaneous reactions as well as the average score for irritation, the test item shows a skin irritating potential under the test conditions chosen and warrants classification and labelling as Skin Irrit. 2, H315.

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
14 May 2012 - 24 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
Principles of method if other than guideline:
The potential of the test item to cause dermal corrosion was assessed by a single topical application of 300 mg of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay).
The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS).
In addition to the test substance, a positive and a negative control were assessed.
GLP compliance:
yes (incl. certificate)
Test system:
artificial membrane barrier model
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 mg (maximum applicable amount)
Duration of treatment / exposure:
1 hour
Observation period:
not applicable
Number of animals:
not applicable
Details on study design:
CONTROLS
Negative control (NC): 10% citric acid (Sigma-Aldrich, Germany)
Positive control (PC): Sodium hydroxide (solid) (Merck, Germany)

TEST SYSTEM
The Corrositex® assay is a standardized in vitro corrosion test. The Corrositex® assay kit is commercially available from InVitro International.
The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS).
The Corrositex® assay is used to determine the corrosive potential of test substances. The assay is limited to testing those materials which cause detectable pH changes in the CDS.
Irritation / corrosion parameter:
penetration time (in minutes)
Value:
> 60
Positive controls validity:
valid

The Corrositex® assay showed the following results:

The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible colour change. Therefore the membrane barrier test method was determined to be suitable for the evaluation of the corrosive potential of the test substance.

A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 2 (having a low acid/alkaline reserve).

In the main test four Corrositex® Biobarrier Membranes were treated with the test substance. The test substance did not break through the Corrositex® Biobarrier Membrane within the maximum observation period of 1 hour.

Test substance

Breakthrough time [min:s]

 

Vial 1

Vial 2

Vial 3

Vial 4

Mean

test item

> 60 min

> 60 min

> 60 min

> 60 min

-

PC: sodium hydroxide, solid

9:10

-

-

-

-

NC: 10% citric acid

NB

-

-

-

 

 

Based on the observed results and applying the evaluation criteria, it was concluded, that the test item does not show a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The result does not exclude an irritation potential of the test substance.

Interpretation of results:
other: not corrosive
Conclusions:
Based on the observed results and applying the evaluation criteria, it was concluded, that the test item does not show a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The result does not exclude an irritation potential of the test substance.
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
30 May 2012 - 24 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Principles of method if other than guideline:
The objective was to assess the potential for corrosive activity and skin irritation of the test material upon first contact with skin. The assessment of the skin corrosion/irritation potential is included in international regulatory requirements for the testing of chemicals. Due to animal welfare reasons corrosivity and skin irritation were determined using the reconstructed human epidermal model EpiDermTM.
GLP compliance:
yes (incl. certificate)
Test system:
human skin model
Observation period:
not applicable
Number of animals:
not applicable
Details on study design:
CONTROLS
Negative control (NC):
De-ionized water (corrosion test);
PBS, sterile (irritation test)

Positive control (PC):
8-n potassium hydroxide solution (Sigma-Aldrich, Munich, Germany) for the corrosion test
5% (w/v) sodium dodecyl sulfate (SDS, Sigma, Germany) in deionized water, sterile for the irritation test

TEST SYSTEM
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.

Tissue model: Epi-200
Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
Irritation / corrosion parameter:
% tissue viability
Value:
2
Negative controls validity:
valid
Positive controls validity:
valid

1. Corrosion Test

 

 

 

Exposure: 3 min

Exposure: 1 h

Test substance

 

Tissue 1

Tissue 2

Mean

Tissue 1

Tissue 2

Mean

NC

mean OD570

2.364

2.287

2.326

2.212

2.105

2.158

Viability [% of NC]

101.7

98.3

100

102.5

97.5

100

Test item

mean OD570

2.104

2.152

2.128

0.110

0.101

0.106

Viability [% of NC]

90.5

92.5

91

5.1

4.7

5

PC

mean OD570

0.359

0.353

0.356

0.104

0.161

0.132

Viability [% of NC]

15.4

15.2

15

4.8

7.5

6

 

2. Irritation Test

 

Test substance

 

Tissue 1

Tissue 2

Tissue 3

Mean

SD

NC

mean OD570

2.151

2.318

2.358

2.275

 

Viability [% of NC]

94.5

101.9

103.6

100

4.83

Test item

mean OD570

0.044

0.044

0.042

0.043

 

Viability [% of NC]

1.9

1.9

1.8

2

0.06

PC

mean OD570

0.051

0.051

0.053

0.052

 

Viability [% of NC]

2.2

2.2

2.3

2

0.06

 

Interpretation of results:
other: Skin corr. 1, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that the test substance shows a skin corrosion potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
e.g. 24 h occluded exposure, 48 h scoring missing, observation period only 72 h
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+72 h
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24+72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Interpretation of results:
other: Skin irrit. 2, H315. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Kleinrusse
Details on test animals or tissues and environmental conditions:
According to Guideline.
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
n.a.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 14 days

Cornea

           time (hrs)                           time (days)
           1      6       24      48     72     7     10     14     17      21
mean A     0.75   0.75    1       1      1      1     0.75   0.75   0.75    0.75
mean B     1.5    1.25    4       3.25   3.25   2.75  2.25   2.25   2.25    1.75

A = cloudiness grade
B = cloudiness surface


Cornea (0.5 % aqueous fluorescein): mean 100 or 40 after 24 hrs or 21  days p.a.


Conjunctivae

           time (hrs)                           time (days)
           1      6       24      48     72     7     10     14     17      21
mean A     1      2       2.25    2.75   2.75   2.25  1.5    1.25   1.25    1.25
mean B     1.25   1       1.25    1      1      0.5   0.25   0      0       0
mean C     3      3       3       3      3      1     2.25   1.75   1.75    0.75

A = erythema
B = chemosis
C = exsudation

Reversibility: no

Interpretation of results:
other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
n.a.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Grade 1 in one animal
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Grade 1 in two animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
other: Eye irrit. 2, H319. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
n.a.
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1977-12-15 to 1978-03-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Guideline study performed before GLP was set into force.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Marland Breeding Farms, Inc
- Age at study initiation: Not available
- Weight at study initiation: Not available
- Housing: animals were individually housed
- Diet (e.g. ad libitum): Not available
- Water (e.g. ad libitum): Not available
- Acclimation period: Not available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not available
- Humidity (%): Not available
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): Not available


IN-LIFE DATES: From: 1977-12-15 To: 1978-03-10
Vehicle:
water
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (eye non rinsed /rinsed)
- Concentration (if solution): 50% w/w solution of test material in distilled water (22% a.i.)
Duration of treatment / exposure:
Six rabbits were divided into two treatment groups: 0.1 ml of a 50% w/w solution of the test material (B0010) in distilled water was instilled into one eye each of three rabbits (Group I); a second group of three rabbits received the same treatment as group I, followed at 4 seconds by a 20 ml lukewarm tap water rinse (Group II).
Observation period (in vivo):
1 hour , and on days 1, 2, 3, 4, 7 ,14, 21 and 28 following compound administration.
Number of animals or in vitro replicates:
Group I - 3 animals (50% w/w solution of test material B0010 in distilled water, non-rinsed)
Group II - 3 animals (50% w/w solution of test material B0010 in distilled water, rinsed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group I - Unwashed, Group II washing with 20 ml lukewarm tap water
- Time after start of exposure: 4 seconds in group II


SCORING SYSTEM: Draize Scoring System


TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Day 1-3
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Day 1-3
Score:
0.8
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Day 1-3
Score:
2.1
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Day 1-3
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
Group I (Unwashed eye)
Overall irritation score at 1 hour: 6
Overall irritation score at 1 day: 7.67
Overall irritation score at 2 days: 6.67
Overall irritation score at 3 days: 5.33
Overall irritation score at 4days: 5.33
Overall irritation score at 7 days: 3.33
Overall irritation score at 14 days: 0.33
Overall irritation score at 21 days: 0.66
Group II (Washed eyes)
Overall irritation score at 1 hour: 4.00
Overall irritation score at 1 day: 6.34
Overall irritation score at 2 days: 5.33
Overall irritation score at 3 days: 4.33
Overall irritation score at 4 days: 4.33
Overall irritation score at 7 days: 1.66
Overall irritation score at 14 days: 1.33
Overall irritation score at 21 days: 0
Overall irritation score at 28 days: 0
Other effects:
None

Irritation parameter   Basis  Time point    Max. score  Reversibility  Remarks
 overall irritation score  mean  14 and 21 days    0.66  not fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
 Cornea score and iris score  mean  14 and 21 days  0  0  othere: No corneal and iridal irritation was observed  0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
 conjunctivae and chemosis score  mean one animal with grade 1, two animals with grade 0  14 and 21 days > = 0 -< = 1  1  not fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
  overall irritation score  mean  1 hour    4.00  fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed
 cornea score  mean three animals with grade 1  1 hour  1  1 fully reversible within: 21 days     0.1 ml of 50% w/w solution of test material in distilled water, rinsed
 Iris score  mean 1hour  0  0  other: no iridal irritation was observed   0.1 ml of 50% w/w solution of test material in distilled water, rinsed
 conjunctivae score  mean one animal with grade 1, two animals with grade 2  1 hour  > =1 -< =2  2  fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 chemosis score  mean one animal with grade 2, two animals with grade 1  1 hour  > =1 -<=2  2  fully reversible within: 7 days    0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 overall irritation score  mean  1 days    6.34   fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 cornea score  mean one animal with grade 1, two animals with grtade 2  1 days > = 1 - <=2  2   fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 iris score  mean two animals with garde 1, one animal with grade 0  1, 2, 3 and 4 days  > =0 - <=1  1  fully reversible within: 7 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score  mean two animals with grade 2, one animal with grade 3  1 and 2 days  > =2 - <=3   3  fully reversible within: 21 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 chemosis score  mean one animal grade 0, one animal with grade 2, one animal with grade 3  1 days  >=0 - <=3  3  fully reversible within: 7 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 overall irritation score  mean  2 days    5.33  fully reversible within: 21 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 cornea score  mean two animals with grade 2, one animal with grade 0  2, 3 and 4 days  >=0 -<=2  2  fully reversible within: 21 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
chemosis score  mean one animal with grade 0, one animal with grade1, one animal with grade 2 2 and 3 days    >= 0- <=3  3  fully reversible within: 7 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 overall irritation score  mean  3 and 4 days    4.33  fully reversible within: 21 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 conjunctivae score  mean two animals with grade 2, one animal with grade 0 3 and 4 days   >= 0 -<=2  2   fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 overall irritation score  mean  7 days   1.66   fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 cornea score  mean one animal with grade 0, one animal with grade 1, one animal with grade 3  7 days  >= 0 -<=3  3   fully reversible within: 21 days  0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 iris score  mean  7 and 14 days  0  0    other : no iridal irritation was observed  0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 conjunctivae score  mean one animal with grade 1, two animals with grade 0  7 and 14 days >=0 -<=1   1    fully reversible within: 21 days   0.1 ml of 50% w/w solution of test material in distilled water, rinsed  
 chemosis score  mean  7 and 14 days  0  0 other : no conjunctival chemosis was observed   0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 overall irritation score  mean  14 days    1.33    fully reversible within: 21 days    0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 cornea score  mean one animal with grade 0, one animal with grade 1, one animal with grade 3  14 days  >=0 - <=3  3    fully reversible within: 21 days    0.1 ml of 50% w/w solution of test material in distilled water, rinsed 
 overall irritation, cornea, conjunctivae and chemosis score  mean  21 and 28 days  0  0 other : no ocular irritation was observed    0.1 ml of 50% w/w solution of test material in distilled water, rinsed 

GHS Rating and Calculations

 Animals no.  GHS Classification  What It means?  Cornea  Iris  Conjunctival redness  Conjunctival chemosis  Days to clear
 354  2a  Irritating to eyes  2  0.67  2  1.67  21 days
 355  2a  Irritating to eyes  2  0.67  2  1.33 21 days 
 356  2a  Irritating to eyes  2  1  2.33  2  21 days
Interpretation of results:
other: Eye irrit. 2, H319. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)
Conclusions:
Regarding the fact that only one animal showed very slight effects on Day 28, a trigger for a classification as highly irritant is not justified. Hence, 22% a.s. potassium alkyl sulfates paste is irritating to the eyes.
Executive summary:

Six rabbits were divided into two treatment groups: 0.1 ml of a 50% w/w solution of the test material B0010 (44% KAS paste) in distilled water was instilled into one eye each of three rabbits (Group I); a second group of three rabbits received the same treatment as group I, followed at 4 seconds by a 20 ml lukewarm tap water rinse (Group II). The eyes were examined for corneal opacity, iritis and conjunctivitis at one hour and on days 1, 2, 3, 4, 7, 14, 21 and 28 following treatment and were graded using Draize ocular irritation grading system.

All three eyes in Group I were assigned positive scores for corneal opacity and ulceration, iritis, conjunctival redness and chemosis. Two eyes were clear on day 28 of the study and showed signs of eye irritation on day 21 of the study.

Three eyes in Group II were assigned positive scores for corneal opacity. Three eyes were observed to have positive scores for conjunctival redness and two for chemosis. In addition, two eyes were assigned positive score for iritis. One eye was clear on day 3 and two on day 21 of the study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no study data on skin and eye irritation / corrosion available for Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt. Therefore, these endpoints are covered by read across to structurally related alkyl sulfates (AS) in accordance with Regulation (EC) No. 1907/2006 Annex XI 1.5 “Grouping of substances and read-across approach”. In Annex XI 1.5 it is given that a read-across approach is possible for substances whose physico-chemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS read-across approach show structural similarity. The most important common structural feature of the source and target substances is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralized with a counter ion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the source and target substances in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS have similar physico-chemical, environmental and toxicological properties. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

 

Skin irritation

For the analogue substance Sodium octyl sulfate (C8 AS Na, CAS 142-31-4) there are two in vitro studies and one in vivo study available. Moreover, in vivo studies are also available for Sulfuric acid, mono (2-ethylhexyl) ester, sodium salt (C8 iso AS Na, CAS 126-92-1) and Sodium dodecyl sulfate (C12 AS Na, CAS 151-21-3). All available studies as well as additional published data from literature are accounted for in a Weight-of-Evidence (WoE) approach.

 

The first in vitro study was performed as a combined OECD guideline 431 and 439 study (Epiderm assay, BASF 2012b). The test substance (pH 8) was applied on reconstructed human epidermal model EpiDermTM. For the corrosion test two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator) and test group (test material, negative control and positive control) were used. 25 μL de-ionized water was applied to the reconstructed dermis before a bulk volume of 25 μL of the solid ground test material was applied and homogeneously distributed. After treatment for 3 and 60 min, respectively the epidermal model was washed and the viability of the cells was assessed via MTT reduction. The mean viability after 3 and 60 min exposure were 91 and 5% of control, respectively. For the irritation part of this experiment three tissues were treated with the test substance. 25 μL sterile PBS was applied before a bulk volume of 25 μL of the solid ground test material was applied. The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Subsequently, the tissues were incubated at 37°C for a total of 42 hours. After the post-incubation period the viability of the cells was assessed via MTT reduction. The mean viability was 2% of control. Thus, according to the evaluation and acceptance criteria C8 AS Na (CAS 142-31-4) showed corrosive properties within this combined OECD guideline 431 and 439 study.

 

The second in vitro study with C8 AS Na (CAS 142-31-4) was performed according to OECD Guideline 435 (Corrositex assay, BASF 2012c). The potential of the test item to cause dermal corrosion was assessed by a single topical application of 300 mg of the test substance (maximum applicable amount) to the Corrositex® Biobarrier Membrane. The time required for the test substance to penetrate through the membrane is used as a marker of dermal corrosion. The test substance did not penetrate through the membrane within 60 minutes. Based on the observed results and applying the evaluation and acceptance criteria, the test item does not show a corrosive potential within this study.

 

The results of the in vitro tests are contradictory, although both studies followed known testing guidelines without deviations reported. To assess whether or not C8 AS Na (CAS 142-31-4) exhibits skin corrosive properties in vivo, the acute dermal toxicity study was re-evaluated with focus on skin irritation upon application of the test substance. During this study (BASF, 2012a; cf. IUCLID section 7.2.3 Acute toxicity: dermal) no signs of irritation after application of the test substance for 24 h were observed. This indicates the test substance to be not corrosive and therefore challenges the corrosive result achieved within the Epiderm assay. Although skin corrosive properties seemed to be very unlikely when regarding the acute dermal toxicity study, skin irritating potential could not be excluded. To further explore the contradictory results of the in vitro studies, existing literature examining the irritating effects of alky sulfates as a function of the carbon chain length was evaluated. A total of six publications were considered. Details on the studies are summarised in IUCLID section 7.12: Additional toxicological information. A summary of these studies is given below. After evaluation of the literature it seemed to be even more unlikely that C8 AS Na (CAS 142-31-4) has skin corrosive properties. Therefore it was considered to be reasonable and justified to perform an in vivo skin irritation study.

 

In an OECD guideline 404 study C8 AS Na (CAS 142-31-4) was applied to 3 New Zealand rabbits under semi-occlusive conditions for 4 h (BASF, 2012d). Skin reactions were scored 1, 24, 48 and 72 h after removal of the patch. The observation period was 14 days. Clinical observations comprised of scaling to severe scaling, incrustations, eczema like lesions, bloody, yellowish incrustations, yellowish discoloration of application site and plaque like incrustations. The mean erythema score after 24, 48 and 72 h was 3 for each rabbit. The mean edema scores after 24, 48 and 72 h were 2, 3.3 and 3 for animals 1, 2 and 3, respectively. Erythema and edema were not fully reversible within 14 days. Thus, the test substance was classified as skin irritating Category 2 according to Regulation (EC) No. 1272/2008 (CLP).

 

In addition, an in vivo study was performed with C8 iso AS Na (CAS 126-92-1, analytical purity: 37.5%) similar to OECD Guideline 404 under occlusive conditions (BASF, 1978b). Each of six rabbits of the Russian strain was exposed for 24 h to 0.5 mL of the unchanged test item and was observed for a period of 7 days for erythema and edema. The mean erythema and edema score after 24, 48 and 72 h were 0.61 and 0.22. The erythema was fully reversible within 72 h and the edema was fully reversible within 48 h. Thus the test substance does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) at a concentration of 37.5% a.i under the stringent conditions used within this study.

 

Another study conducted with C12 AS Na (CAS 151-21-3, analytical purity 100%) was performed similar to OECD Guideline 404 under occlusive conditions (BASF, 1976b). Each of six New Zealand White rabbits was exposed for 24 h to 0.5 mL of the unchanged test item and was observed for a period of 72 h for erythema and edema. No scoring was done 48 h after application. The mean erythema and edema score after 24 and 72 h were 2.2 and 1.7. Both were not reversible within 72 h. When using the higher value of the 24 and 72 h reading time point as value for the 48 h value (per animal) the mean erythema and edema score of all animals were 2.4 and 2.2, respectively.

 

Evaluation of the irritating potential of alkyl sulfates as a function of their chain length

In an in vivo study with rabbits the effect of a series of sodium alkyl sulfates of chain lengths C8 to C18 on the conjunctivae of rabbit eyes was assessed according to Draize (Daweke, 1959). Upon instillation of 0.1 mL aqueous solutions into the conjunctival sac of the rabbit eye effects were recorded at regular time intervals and the mean Draize score of 18 parallel experiments was determined. Both at equimolar concentrations (86.5 mM) and 2.5% w/w a maximum of irritancy was observed for C12 alkyl sulfate. Although this study investigated the irritating potential of alkyl sulfates in dependency of the alkyl chain length on the eye it is expected that the results achieved are also applicable for assessing trends on the irritating effects on skin.

 

In addition to this in vivo study on rabbit eyes there are three studies conducted on the skin of human volunteers available. The skin irritating effects of sodium alkyl sulfates of carbon chain lengths from C8 to C16 was assessed after application to the backs of 10 human volunteers in the scapular region (Kligman, 1967). The skin was exposed to a series of five concentrations under occlusive conditions and after 24 hours for each compound. The percentage of volunteers exhibiting a discernible erythema was determined. The percentage of volunteers showing erythema was plotted against the log of applied concentrations. The ID50 (concentration producing erythema in 50% of the volunteers) was calculated from the graph. ID50 values plotted against the carbon chain length of tested alkyl sulphate showed a maximum of irritancy at C12 followed by C10, C14, C16 and C8.

 

A further study with human volunteers assessing skin irritancy as a function of varying carbon chain lengths ranging from C8 to C18 was performed with sodium alkyl sulfates (Schulz, 1957). The skin of the inner forearms of 20-25 volunteers was exposed to 0.1% and 0.25% aqueous solutions of alkyl sulfate for 22-24 h under occlusive conditions and the number of volunteers exhibiting skin reactions was recorded. Irritating effects were observed in 17/25 human volunteers for C12, 10/25 human volunteers for C10, 10/25 human volunteers for C14 and 3/25 human volunteers for C8 chained alkyl sulfates. The alkyl sulfates of chain lengths C16 and C18 gave no reactions on any volunteer.

 

Another available study with human volunteers measured the transepidermal water loss (TEWL) and occurrence of erythema after application of sodium alkyl sulfates with variable carbon chain length from C8 to C16 (purity >99%; Wilhelm, 1993). 20 mM aqueous solutions of alkyl sulfates of varying chain lengths were applied for 24 hours under occlusive conditions to the volar forearm of volunteers. TEWL was measured with an evaporation meter and erythema was objectively quantitated by skin colour reflectance measurements with a chromameter. Increasing barrier damage (TEWL increase) and increasing erythema were observed with increasing alkyl chain length with maximum effects at C12.

 

The results of the human volunteer studies were confirmed by the results of two in vitro studies. The swelling of excised abdominal human skin discs in the presence of sodium alkyl sulfates at different concentrations was investigated by Choman (1961). Alkyl chain lengths from C8 to C18 (>99% purity) were used. Each skin disc was placed individually in a screw cap test tube containing 20 ml solution and was fully submerged. The discs were removed and thickness was assessed with a micrometre dial gauge. Change in thickness was calculated in terms of percentage difference between initial thickness and thickness following treatment. By plotting the percentage swelling versus log concentration, a straight line was observed. When the slopes of the swelling curves were plotted as a function of carbon chain length of each tested compound the greatest swelling response was observed for the C12 alkyl sulfate. Carbon chain lengths of C10 and C14 produced a lower swelling response followed by C8, C16 and C18.

 

In a second in vitro study discs of membrane tissue were set up in glass diffusion cells filled with 5 mM solutions of alkyl sulfates of various chain lengths from C8 to C16. Epidermal electrical conductance was measured by means of stainless steel electrodes (Dugard, 1973). A clear correlation between alkyl chain length and the rate of change of electrical conductance was established with a maximum at C12. This change in electrical conductance decreased from C14 to C16 and was absent at C8.

 

Conclusion on skin irritation

Taken together, it can be concluded that irritating effects of alkyl sulfates will be maximum at carbon chain length of C12. The irritating properties will decrease with both increasing and decreasing carbon chain length. Results achieved with C12 alkyl sulfates within the AS category indicate that alkyl sulfates are irritating to the skin. Thus, these results are in line with and support the classification and labelling warranted for Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt as assessed based on read-across to CAS 142-31-4. Based on all results available with different concentrations of structurally related alkyl sulfates and varying carbon chain length, it can be expected that Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt exhibits irritating properties to the skin. Therefore, according to Regulation (EC) No. 1272/2008 (CLP) the target substance has to be classified as skin irrit. 2, H315.

 

Eye irritation

Regarding eye irritation one relevant key study with the read-across substance Sodium dodecyl sulfate (C12 AS Na, CAS 151-21-3) is available.

 

In the key study according to OECD guideline 405 (BASF, 1987) 0.1 mL of C12 AS Na (CAS 151-21-3, analytical purity 25%) was applied to one eye of each of four rabbits (strain: Kleinrusse Chbb:HM). Eye reactions were scored 1, 6, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days after application. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores were 1, 0, 2.6 and 1.1. The corneal and the conjunctival findings did not fully reverse with the 21 days of observation.. Thus the test item produced irreversible effects on the eye at a concentration of 25 %.

 

Setting of SCLs for eye irritation

As corrosion and irritation depends on the concentration of a substance, further supporting studies with lower concentrations of read across source substances were also considered to assess whether specific concentration limits can be set. For this purpose, one study with Sulfuric acid, mono-C12-13-alkyl esters, potassium salts (C12-13 AS K, CAS 91783-22-1) and two studies with Sulfuric acid, mono-C10-16-alkyl esters, sodium salts (C10 -16 AS Na, CAS 68585-47-7) were evaluated.

 

In the study with C12-13 AS K (CAS 91783-22-1, analytical purity 44%) 0.1 mL of the diluted test item (1:1 mixture with water) was applied to one eye of each of three New Zealand White rabbits according to OECD guideline 405 (P&G, 1978b) without rinsing. In a second experiment with additional 3 rabbits the procedure was repeated but the treated eye was rinsed with 20 mL of lukewarm tap water 4 seconds after application of the test item. The eye reactions were recorded 1, 24, 48, 72 h and 4, 7, 14, 21 and 28 days in both experiments. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores of experiment 1 were 2, 0.8, 2.1 and 1.7. The findings reversed in 2/3 animals within 14 days while 1/3 animals showed signs of irritation after 21 days. However, the signs of irritation show a clear tendency to decrease with time. No reading on day 28 was possible. Findings in the experiment with rinsing of the eye were less pronounced but irritating properties were also observed. As the ocular findings clearly reversed within 21 days the result of the study indicate the concentration of 22% to be the turning point between classification as severe damage to the eye and eye irritation.

 

The first study with 0.1 mL undiluted C10-16 AS Na (CAS 68585-47-7, analytical purity 10%) was performed similar to OECD guideline 405 (Stepan, 1980a) on three New Zealand White rabbits with an observation period of 7 days. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 1.4, 0.7, 2 and 1.6. Corneal opacity was still observed in 1/3 animals (score 1) and conjunctival redness was still present in 2/3 animals (both score 1) upon reading at day 7. The test substance is therefore considered to be irritating to the eye according to the criteria of Regulation (EC) No. 1272/2008 (CLP) at a concentration of 10%.

 

The second study with C10-16 AS Na (CAS 68585-47-7, analytical purity 10%) was performed similar to OECD guideline 405 (Stepan, 1980b). 0.1 mL of the undiluted test item was instilled into one eye of each of three New Zealand White rabbits. Eye reactions were scored at least 24, 48 and 72 h and 14 days after application of the test item. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores were 0.9, 0.7, 1.9 and 1.6. All findings were fully reversible within the observation period. Thus, the test substance showed no eye irritating properties at a concentration of 10%.

 

Conclusion on eye irritation

Based on the above results with different concentrations of structurally related alkyl sulfates a cut of value for classification as severe irritating to eyes is set at a concentration of 20% and for classification as irritating at a concentration of 10%. Since the available data of the read-across substance C10-16 AS Na (CAS 68585-47-7) indicates no or only mild eye irritation potential at a concentration of 10%, no classification is required below 10%. According to Regulation (EC) No. 1272/2008 (CLP) ≥ 20% Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt needs to be classified as H318, Eye Dam. 1. Based on a weight of evidence approach ≥ 10 % < 20% Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt has to be classified as Eye Irrit. 2, H319. No classification with respect to eye irritation is required at concentrations < 10%.

 

Therefore, Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt is considered to be severely eye damaging at concentrations above 20% (Eye Dam. 1, H318) and irritating to eyes (Eye Irrit. 2, H319) in the concentration range 10 - 20%.

 

Respiratory irritation

No data on respiratory irritation are available. AS are mainly used in liquid media and due to their very low vapour pressure [2] inhalation is not considered as a significant route of exposure. Inhalation of AS may occur by inhalation of aerosols generated by spray cleaners or by inhalation of detergent dusts (e.g. washing powder). In both cases the substance will be used in low concentrations. However, in case the substance is available as neat powder the substance (bulk density < 400 g/L) will also be classified as STOT SE 3, H335, according to Regulation (EC) No. 1272/2008 (CLP) at concentrations exceeding 20% in order to reflect the irritating properties of the substance.

 

[1] SIDS initial assessment profile, (2007); http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf

[2] (HERA Draft report, 2002); http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP) the test substance needs to be classified as Skin Irrit. 2, H315, and Eye Dam. 1, H318, respectively. As the neat substance has to be classified as skin and eye irritating, the substance will also be classified as “may cause respiratory irritation” (STOT SE3, H335) in case the substance is available as neat powder. It could be shown with experimental data on eye irritation that at 10 to 20% active substance only the classification Eye Irritating Category 2 according to Regulation (EC) No. 1272/2008 (CLP) is applicable. Below 10% active substance no classification with respect to eye irritation is necessary. Hence, the Generic Concentration Limits (GCLs) can be substituted by the mentioned specific ones (SCLs).